- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01887288
Capecitabine With Digoxin for Metastatic Breast Cancer
January 22, 2018 updated by: Western Regional Medical Center
Metronomic Capecitabine With Digoxin for Metastatic Breast Cancer Progressing After Anthracycline and Taxane Treatment
To evaluate the Growth Modulation Index (GMI) of the combination of metronomic capecitabine with oral digoxin in metastatic breast cancer
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Detailed Description
In this phase II study, the Investigators will combine metronomic capecitabine with digoxin to treat metastatic breast cancer patients who have progressed on both anthracyclines and taxanes.
We hypothesize that the combination of digoxin with metronomic capecitabine may lead to increased efficacy and duration of treatment without progression with decreased side effects than standard regimen.
Study Type
Interventional
Enrollment (Actual)
16
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Arizona
-
Goodyear, Arizona, United States, 85338
- Western Regional Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients ≥ 18 years of age with histologically confirmed, metastatic breast cancer resistant to anthracyclines and taxanes
- Anthracycline resistance is defined as tumor progression during treatment or within 3 months of last dose in the metastatic setting, or recurrence within 6 months in the neoadjuvant or adjuvant setting. Alternatively, a minimum cumulative dose of anthracycline of 240 mg/m^2 (doxorubicin) or 360 mg/m^2 (epirubicin) has been reached, or there is contraindication to use anthracycline, the patient is also eligible
- Taxane resistance is defined as recurrence within 4 months of the last dose in the metastatic setting or within 12 months in the adjuvant setting
- Having progressed on anti-HER2 or hormonal therapy if they have HER2 positive or hormone-receptor positive breast cancer
- Eastern Cooperative Oncology Group (ECOG) performance status score ≤ 2 and a life expectancy >3 months.
- Participants must have at least one target lesion as defined by RECIST 1.1 that allows for evaluation of tumor response
- Absolute neutrophil count ≥ 1500 mm3, platelet count ≥ 100×109 L, hemoglobin ≥ 8.5 g/dL
- Serum creatinine ≤1.5 times the upper limit of the normal range, total bilirubin ≤ 2 mg/dL, AST/ALT ≤ 5 times the upper limit of normal range
- No remaining grade 2 or higher toxicity from prior cancer therapies unless judged to be clinically insignificant by the Principal Investigator
- At least three (3) weeks from prior chemotherapy
- Women of child-bearing potential (i.e., women who are pre-menopausal or not surgically sterile) must be willing to use an acceptable contraceptive method (abstinence, oral contraceptive or double barrier method) for the duration of the study and for 30 days following the last dose of study drug, and must have a negative urine or serum pregnancy test within 2 weeks prior to beginning treatment on this trial.
Exclusion Criteria:
- Inadequate renal function with a calculated creatinine clearance less than 51 mL/min.
- History of ventricular fibrillation, sinus node or AV nodal disease, Wolff Parkinson White Syndrome, hemodynamically significant or life threatening cardiac arrhythmia.
- Uncontrolled cardiac disease, congestive heart failure, angina or hypertension.
- Myocardial infarction or unstable angina within 2 months of treatment.
- Known human immunodeficiency virus (HIV) infection or chronic active Hepatitis B or C (patients are NOT required to be tested for the presence of such viruses prior to therapy on this protocol).
- Active clinically serious infection > CTCAE (version 4.03) Grade 2.
- Thrombotic or embolic events such as a cerebrovascular accident including transient ischemic attacks within the past 6 months.
- Pulmonary hemorrhage/bleeding event ≥ CTCAE Grade 2 within 4 weeks of first dose of study drug.
- Any other hemorrhage/bleeding event ≥ CTCAE Grade 3 within 4 weeks of first dose of study drug.
- Serious non-healing wound, ulcer, or bone fracture.
- Major surgery or significant traumatic injury within 2 weeks of first study drug.
- Inability to complete informed consent process and adhere to the protocol treatment plan and follow-up requirements.
- Concurrent severe illness such as active infection, or psychiatric illness/social situations that would limit safety and compliance with study requirements.
- Currently on anti-coagulation therapy with Coumadin, and cannot be switched other forms of anti-coagulation.
- Patients have symptomatic untreated brain metastasis or leptomeningeal metastases or treated but still symptomatic requiring the use of steroid within the past two weeks.
- Patients receiving any other investigational agents. Pregnant or Lactating females.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Capecitabine with Digoxin
Capecitabine PO daily b.i.d., no breaks, starts at day 1 of the first cycle; Digoxin: once daily, starts at day -7 of the first cycle (1 cycle - 4 weeks) |
650 mg/m^2 PO b.i.d.
Other Names:
0.25 mg once daily
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Metronomic Capecitabine With Oral Digoxin
Time Frame: One year
|
Evaluate the Growth Modulation Index (GMI) of the combination of metronomic capecitabine with oral digoxin in metastatic breast cancer
|
One year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Combination Overall Clinical Benefit by RECIST 1.1
Time Frame: One year
|
Assess the activity of this combination in terms of overall clinical benefit rates (CBR), including complete response (CR), partial response (PR) or stable disease (SD) as defined by Response Evaluation Criteria in Solid Tumors (RECIST 1.1)
|
One year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jiaxin Niu, MD, PhD, Western Regional Medical Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2013
Primary Completion (ACTUAL)
November 1, 2015
Study Completion (ACTUAL)
November 1, 2015
Study Registration Dates
First Submitted
June 24, 2013
First Submitted That Met QC Criteria
June 24, 2013
First Posted (ESTIMATE)
June 26, 2013
Study Record Updates
Last Update Posted (ACTUAL)
February 22, 2018
Last Update Submitted That Met QC Criteria
January 22, 2018
Last Verified
January 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Skin Diseases
- Neoplasms
- Neoplasms by Site
- Breast Diseases
- Breast Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Enzyme Inhibitors
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Protective Agents
- Cardiotonic Agents
- Digoxin
- Capecitabine
Other Study ID Numbers
- WRMC 13-05
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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